A Prospective and Randomized Study of Efficacy and Safety of Transdermal Oxybutynin Versus Oral Oxybutynin in the Management of Children with Overactive Bladder.

BACKGROUND

The present study was conducted in the pediatric urology outpatient clinic of a tertiary referral hospital and included children with persistent symptoms of overactive bladder (OAB) despite prior conservative management.

AIM: To compare the efficacy and safety of oral and transdermal oxybutynin in the treatment of non-neurogenic OAB in children.

METHODS

The present prospective, randomized controlled clinical study was conducted at a tertiary pediatric urology outpatient clinic between January 1 and July 1, 2019. A total of 90 children were initially enrolled. After exclusion of seven patients due to incomplete follow-up data, 83 patients were included in the final analysis. Patients were randomized in a 1:1 allocation ratio to receive either oral oxybutynin (n = 42) or transdermal oxybutynin (n = 41). Symptom severity and treatment response were assessed using the Dysfunctional Voiding and Incontinence Symptom Score (DVISS), bladder diary, and uroflowmetric parameters. Pre- and post-treatment values were compared within and between groups. Adverse effects were documented based on patient-reported symptoms and clinical observation. Continuous variables in two dependent groups were compared using the Wilcoxon test. Continuous variables in two independent groups were analyzed using the Mann-Whitney test. Fisher's exact test was used to compare proportions between groups.

RESULTS

Both groups demonstrated statistically significant improvements in DVISS, voided volume, and urinary frequency after treatment ( P < 0.05). No significant difference in treatment efficacy was found between oral and transdermal administration. Adverse reactions were observed in 40.5% (n = 17) of group 1 and 43.9% (n = 18) of group 2 ( P = 0.826). However, non-skin-related systemic adverse events were significantly more frequent in the oral oxybutynin group compared with the transdermal group (38% vs. 9.8%, P = 0.004). None of the adverse effects observed in either group were severe enough to require discontinuation of treatment.

CONCLUSION

Transdermal oxybutynin is as effective as oral oxybutynin in managing pediatric non-neurogenic OAB, with a more favorable systemic side effect profile. It represents a viable alternative for patients who experience difficulty with oral medication or intolerance to systemic anticholinergic side effects.